Smart Messages and Alerts for an Infusion Delivery and Management System

ABSTRACT

Method and system for providing diabetes management is provided.

RELATED APPLICATION

The present application is a continuation of U.S. patent applicationSer. No. 11/365,168 filed Feb. 28, 2006, the disclosure of which isincorporated herein by reference for all purposes.

BACKGROUND

With increasing use of pump therapy for Type 1 diabetic patients, youngand old alike, the importance of controlling the infusion device such asexternal infusion pumps is evident. Indeed, presently available externalinfusion devices typically include an input mechanism such as buttonsthrough which the patient may program and control the infusion device.Such infusion devices also typically include a user interface such as adisplay which is configured to display information relevant to thepatient's infusion progress, status of the various components of theinfusion device, as well as other programmable information such aspatient specific basal profiles.

The external infusion devices are typically connected to an infusion setwhich includes a cannula that is placed transcutaneously through theskin of the patient to infuse a select dosage of insulin based on theinfusion device's programmed basal rates or any other infusion rates asprescribed by the patient's doctor. Generally, the patient is able tocontrol the pump to administer additional doses of insulin during thecourse of wearing and operating the infusion device such as for,administering a carbohydrate bolus prior to a meal. Certain infusiondevices include food database that has associated therewith, an amountof carbohydrate, so that the patient may better estimate the level ofinsulin dosage needed for, for example, calculating a bolus amount.

However, in general, most estimation or calculation of a bolus amountfor administration, or a determination of a suitable basal profile, forthat matter, are educated estimates based on the patient's physiology asdetermined by the patient's doctor, or an estimate performed by thepatient. Moreover, the infusion devices do not generally includeenhancement features that would better assist the diabetic patients tocontrol and/or manage the glucose levels.

In view of the foregoing, it would be desirable to have an approach toprovide methods and system for providing proactive notifications to thepatients using infusion devices that may assist in better controllingand treating diabetes, such as for example, by programming the pumpand/or determining frequency of event occurrences that are relevant todifferent types of diabetes-associated episodes such as hyperglycemicstate, hypoglycemic state, monitoring of glucose levels and the like.

SUMMARY OF THE INVENTION

In accordance with the various embodiments of the present invention,there are provided methods and system for notification of patientparameters and physiological states to prompt the user to take proactivemeasures such as additional capillary blood glucose testing, consumptionof snacks, and/or other diabetes management related alerts to thepatient prior to the onset of the relevant condition such that thepatients may better control the glucose levels during the course of theday when using an insulin infusion pump. In addition, system and methodsin accordance with the present inventions include data analysis of thepatient's glucose levels over extended periods of time to generatenotification to the patients to inform them of the analysis results soas to provide additional motivation or incentive to improve upon theexisting glucose management.

These and other objects, features and advantages of the presentinvention will become more fully apparent from the following detaileddescription of the embodiments, the appended claims and the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram illustrating an insulin therapy managementsystem for practicing one embodiment of the present invention;

FIG. 2 is a block diagram of an insulin delivery device of FIG. 1 in oneembodiment of the present invention;

FIG. 3 is a flow chart illustrating a notification procedure to preventDKA from persistent high blood glucose level in accordance with oneembodiment of the present invention;

FIG. 4 is a flow chart illustrating a notification procedure forminimizing nocturnal hypoglycemia in accordance with one embodiment ofthe present invention;

FIG. 5 is a flow chart illustrating a notification procedure forimproving blood glucose level control in a patient in accordance withone embodiment of the present invention; and

FIG. 6 is a flow chart illustrating a notification procedure forimproving blood glucose level control in a patient in accordance withanother embodiment of the present invention.

DETAILED DESCRIPTION

FIG. 1 is a block diagram illustrating an insulin therapy managementsystem for practicing one embodiment of the present invention. Referringto FIG. 1, the insulin therapy management system 100 includes an analytemonitoring system 110 operatively coupled to an insulin delivery device120, which may be in turn, operatively coupled to a remote terminal 140.As shown the Figure, the analyte monitoring system 110 is, in oneembodiment, coupled to the patient 130 so as to monitor or measure theanalyte levels of the patient. Moreover, the insulin delivery device 120is coupled to the patient using, for example, and infusion set andtubing connected to a cannula (not shown) that is placedtranscutaneously through the skin of the patient so as to infusemedication such as, for example, insulin, to the patient.

Referring to FIG. 1, in one embodiment the analyte monitoring system 110in one embodiment may include one or more analyte sensors subcutaneouslypositioned such that at least a portion of the analyte sensors aremaintained in fluid contact with the patient's analytes. The analytesensors may include, but not limited to short term subcutaneous analytesensors or transdermal analyte sensors, for example, which areconfigured to detect analyte levels of a patient over a predeterminedtime period, and after which, a replacement of the sensors is necessary.

The one or more analyte sensors of the analyte monitoring system 110 iscoupled to a respective one or more of a data transmitter unit which isconfigured to receive one or more signals from the respective analytesensors corresponding to the detected analyte levels of the patient, andto transmit the information corresponding to the detected analyte levelsto a receiver device, and/or insulin delivery device 120. That is, overa communication link, the transmitter units may be configured totransmit data associated with the detected analyte levels periodically,and/or intermittently and repeatedly to one or more other devices suchas the insulin delivery device and/or the remote terminal 140 forfurther data processing and analysis.

The transmitter units of the analyte monitoring system 110 may in oneembodiment configured to transmit the analyte related data substantiallyin real time to the insulin delivery device 120 and/or the remoteterminal 140 after receiving it from the corresponding analyte sensorssuch that the analyte level such as glucose level of the patient 130 maybe monitored in real time. In one aspect, the analyte levels of thepatient may be obtained using one or more of a discrete blood glucosetesting devices such as blood glucose meters, or a continuous analytemonitoring systems such as continuous glucose monitoring systems.

Additional analytes that may be monitored, determined or detected theanalyte monitoring system 110 include, for example, acetyl choline,amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase(e.g., CK-MB), creatine, DNA, fructosamine, glucose, glutamine, growthhormones, hormones, ketones, lactate, peroxide, prostate-specificantigen, prothrombin, RNA, thyroid stimulating hormone, and troponin.The concentration of drugs, such as, for example, antibiotics (e.g.,gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs ofabuse, theophylline, and warfarin, may also be determined.

Moreover, within the scope of the present invention, the transmitterunits of the analyte monitoring system 110 may be configured to directlycommunicate with one or more of the remote terminal 140 or the insulindelivery device 120. Furthermore, within the scope of the presentinvention, additional devices may be provided for communication in theanalyte monitoring system 100 including additional receiver/dataprocessing unit, remote terminals (such as a physician's terminal and/ora bedside terminal in a hospital environment, for example. In addition,within the scope of the present invention, one or more of the analytemonitoring system 110, the insulin delivery device 120 and the remoteterminal 140 may be configured to communicate over a wireless datacommunication link such as, but not limited to RF communication link,Bluetooth communication link, infrared communication link, or any othertype of suitable wireless communication connection between two or moreelectronic devices, which may further be uni-directional orbi-directional communication between the two or more devices.Alternatively, the data communication link may include wired cableconnection such as, for example, but not limited to RS232 connection,USB connection, or serial cable connection.

The insulin delivery device 120 may include in one embodiment, but notlimited to, an external infusion device such as an external insulininfusion pump, an implantable pump, a pen-type insulin injector device,a patch pump, an inhalable infusion device for nasal insulin delivery,or any other type of suitable delivery system. In addition, the remoteterminal 140 in one embodiment may include for example, a desktopcomputer terminal, a data communication enabled kiosk, a laptopcomputer, a handheld computing device such as a personal digitalassistant (PDAs), or a data communication enabled mobile telephone.

Referring back to FIG. 1, in one embodiment, the analyte monitoringsystem 100 includes a strip port configured to receive a test strip forcapillary blood glucose testing. In one aspect, the glucose levelmeasured using the test strip may in addition, be configured to provideperiodic calibration of the analyte sensors of the analyte monitoringsystem 100 to assure and improve the accuracy of the analyte levelsdetected by the analyte sensors.

FIG. 2 is a block diagram of an insulin delivery device of FIG. 1 in oneembodiment of the present invention. Referring to FIG. 2, the insulindelivery device 120 in one embodiment includes a processor 210operatively coupled to a memory unit 240, an input unit 220, a displayunit 230, an output unit 260, and a fluid delivery unit 250. In oneembodiment, the processor 210 includes a microprocessor that isconfigured to and capable of controlling the functions of the insulindelivery device 120 by controlling and/or accessing each of the variouscomponents of the insulin delivery device 120. In one embodiment,multiple processors may be provided as safety measure and to provideredundancy in case of a single processor failure. Moreover, processingcapabilities may be shared between multiple processor units within theinsulin delivery device 120 such that pump functions and/or controlmaybe performed faster and more accurately.

Referring back to FIG. 2, the input unit 220 operatively coupled to theprocessor 210 may include a jog dial, an key pad buttons, a touch padscreen, or any other suitable input mechanism for providing inputcommands to the insulin delivery device 120. More specifically, in caseof a jog dial input device, or a touch pad screen, for example, thepatient or user of the insulin delivery device 120 will manipulate therespective jog dial or touch pad in conjunction with the display unit230 which performs as both a data input and output units. The displayunit 230 may include a touch sensitive screen, an LCD screen, or anyother types of suitable display unit for the insulin delivery device 120that is configured to display alphanumeric data as well as pictorialinformation such as icons associated with one or more predefined statesof the insulin delivery device 120, or graphical representation of datasuch as trend charts and graphs associated with the insulin infusionrates, trend data of monitored glucose levels over a period of time, ortextual notification to the patients.

Referring to FIG. 2, the output unit 260 operatively coupled to theprocessor 210 may include audible alarm including one or more tonesand//or preprogrammed or programmable tunes or audio clips, or vibratoryalert features having one or more pre-programmed or programmablevibratory alert levels. In one embodiment, the vibratory alert may alsoassist in priming the infusion tubing to minimize the potential for airor other undesirable material in the infusion tubing. Also shown in FIG.2 is the fluid delivery unit 250 which is operatively coupled to theprocessor 210 and configured to deliver the insulin doses or amounts tothe patient from the insulin reservoir or any other types of suitablecontainment for insulin to be delivered (not shown) in the insulindelivery device 120 via an infusion set coupled to a subcutaneouslypositioned cannula under the skin of the patient.

Referring yet again to FIG. 2, the memory unit 240 may include one ormore of a random access memory (RAM), read only memory (ROM), or anyother types of data storage units that is configured to store data aswell as program instructions for access by the processor 210 andexecution to control the insulin delivery device 120 and/or to performdata processing based on data received from the analyte monitoringsystem 110, the remote terminal 140, the patient 130 or any other datainput source.

FIG. 3 is a flow chart illustrating a notification procedure to preventDKA from persistent high blood glucose level in accordance with oneembodiment of the present invention. Referring to FIG. 3, in oneembodiment of the present invention, the insulin delivery device 120 maybe programmed such that at step 310, a predetermined number ofconsecutive glucose readings is received over a predefined period oftime. The glucose readings may be received from the analyte monitoringsystem 110 and stored, for example, in the memory unit 240 of theinsulin delivery device 120. For example, in one embodiment, the patientmay be prompted to provide a predetermined number, such as three, ofconsecutive readings of blood glucose measurements over the predefinedtime period such as within a thirty minute window to a four hour window.

Within the scope of the present invention, the insulin delivery device120 may be configured to ascertain these consecutive glucose readingsfrom the data stream received from the analyte monitoring system 110.Moreover, the predefined time period may additionally include any othersuitable time period where the monitored analyte levels may provideinformation associated with the patient's physiological condition aspertains to the insulin therapy and diabetes management. For example,the predefined time period may include a 4-7 day period (or longer orshorter as may be appropriate), where the insulin delivery device 120may be configured to receive the glucose readings at a specific time ofthe day (for example, at 7 am in the morning). In this case, theconsecutive glucose readings may include each measured glucose level at7 am in the morning for the 4-7 day period.

Referring to FIG. 3, at step 320, a predetermined target high glucoselevel which is pre-programmed and pre-stored in the memory unit 240 othe insulin delivery device 120, for example, may be retrieved by theprocessor 210 of the insulin delivery device 120. Alternatively, thepatient may be prompted to provide a suitable target high glucose levelat step 320 by the insulin delivery device 120. Thereafter, at step 330,the consecutive glucose readings over the predefined time periodreceived at step 310 are compared with the target high glucose levelfrom step 320. If it is determined at step 330 that the predeterminednumber of consecutive glucose readings over the predefined time periodare not equal to or greater than the target high glucose level retrievedfrom step 320, then at step 350, the predefined time period may beoptionally reset, and the routine returns to step 310. For example, thesystem may be configured to wait for the subsequent predefined timeperiod, for example, between a time period of 30 minutes to one or twohour windows depending upon the time of the day and also, depending uponthe time of the day in close proximity to a meal or physical activity,as maybe programmed by the patient or the patient's physician or careprovider, before executing the routine as described in FIG. 3 again.

Referring back to FIG. 3, if at step 330 it is determined that thepredetermined number of consecutive glucose readings over the predefinedtime period is greater or equal to the predetermined target high glucoselevel retrieved from memory unit 240 (FIG. 2), or received from thepatient via the input unit 220 (FIG. 2) at step 320, then at step 340,an alert or notification is generated and output to the patient, eithervisually, audibly, tactily, or any combination of the output mechanismsuch as a visual alert displayed on the display unit 230 in combinationwith a vibratory alert providing tactile notification to the patient,and/or an audible alert. In one embodiment, the output alertnotification provided to the patient may include a warning notificationthat the patient's consecutive blood glucose readings are persistentlyabove the predetermined or programmed target high glucose level, andalso, provide recommendation to take possible corrective or confirmatoryactions such as, intake of insulin, and/or additional glucose testingsuch as for example, using fingerstick capillary blood glucosemeasurements. By way of an example, the insulin delivery device 120 maybe configured to display a notification such as, but not limited to:

-   -   “3 High BGs in a Row—Consider Insulin Injection and Site        Change”, “Test Ketones”,    -   “If vomiting Go to Emergency Room”,    -   “Take Insulin Bolus”,    -   “Change Infusion Site”,    -   “Retest Glucose Level in 30 Minutes”,    -   “Call Doctor if Glucose Remains Elevated”,        or any other suitable notification that may assist the patient        in preventing diabetic ketoacidosis (DKA) which is associated        with disruption of insulin delivery. As it is important for        patients using insulin delivery device 120 to prevent going into        DKA on the delivery device 120, the notification may be        accompanied by one or more associated audible or tactile alerts        such that the patients are readily and quickly able to ascertain        the condition for which the insulin delivery device 120 is        prompting the patients, and to take corrective actions        immediately or as soon as possible.

Referring to FIG. 3, in one embodiment, the predetermined target highglucose level stored in the memory unit 240 of the insulin deliverydevice 120 may be 250 mg/dL, and which may be adjustable by the patientor the patient's care provider. For example, a diabetic patientexperiencing thirst and irritation which are generally symptoms ofelevated glucose readings, at 2 pm, determines, based on measuredglucose readings (for example, received from the analyte monitoringsystem 110) that the glucose level is at 263 mg/dL. The patient hasprogrammed the insulin delivery device 120 to a target high glucoselevel of 250 mg/dL, with a predetermined number of consecutive glucosereadings at two readings, and the predefined time period to be a 2 hourwindow.

With the initial glucose reading of 263 mg/dL, the patient may initiallybe prompted to trouble shoot certain settings of the delivery device120, for example, to confirm that the lunch bolus was delivered, noadditional carbohydrate was ingested, verify the infusion tubing (fluiddelivery unit 250) for possible air bubbles. If no settings are in theiraccurate modes, then a correction bolus may be administered using theinsulin delivery device 120. Thereafter, the glucose level after 2 hoursis retrieved, for example, from the memory unit 240 as received from theanalyte monitoring system 110 (including, a separate real time capillaryblood fingerstick testing, for example), and compared with the targethigh glucose level of 250 mg/dL.

If it is determined that the second glucose measurement is still abovethe 250 mg/dL level, then the patient is provided with one or more ofthe alerts or notifications as described above to troubleshoot thepersistent high glucose level condition, and thus take correctivemeasures to avoid the onset of DKA condition.

Referring yet again to FIG. 3, while the above description of processesand routines related to preventing DKA is provided in the context of theinsulin delivery device 120, within the scope of the present invention,the calculation, determination or any programming and data processing toachieve the functions as set forth in FIG. 3 maybe performed eitheralternately or in conjunction with the insulin delivery device 120, bythe analyte monitoring system 110, or the remote terminal 140, as maybeconvenient or practical to the patient 130.

FIG. 4 is a flow chart illustrating a notification procedure forminimizing nocturnal hypoglycemia in accordance with one embodiment ofthe present invention. Referring to FIG. 4, at step 410 a pre-sleep modeis detected. That is, the insulin delivery device 120 may be configuredto automatically enter the pre-sleep mode based on a clock mechanism inthe insulin delivery device 120 which provides real time timing data,and further, in conjunction with the patient specified meal and sleepschedule as maybe individual and different from patient to patient. Forexample, the patient using the insulin delivery device 120 may program apre-sleep mode to be defined as a time period post dinner or the lastmeal of the day, and prior to the patient sleeping. One example may bethe time period of 9 pm to midnight, with the assumption that thepatient has consumed dinner or the last substantial carbohydrate intaketwo to three hours prior to the onset of the pres-sleep mode time periodof 9 pm.

Referring to FIG. 4, upon initiation or detection of the pre-sleep modeat step 410, the insulin delivery device 120 in one embodiment isconfigured to retrieve consecutive glucose readings during the pre-sleepmode time period for example, from the analyte monitoring system 110(FIG. 1). In one embodiment, the number of predetermined consecutiveglucose readings received at step 420 may include three consecutivereadings, two consecutive readings, or any other suitable number ofconsecutive readings that may be appropriate to detecting the potentialonset of hypoglycemic condition.

After receiving the predetermined consecutive glucose readings duringthe pre-sleep time period at step 420, a predetermined and/orpre-programmed target low glucose level is retrieved from, for example,the memory unit 240 of the insulin delivery device 120 (FIG. 2) at step430. Thereafter, at step 440, the predetermined number of consecutiveglucose readings are each compared with the predetermined target lowglucose level (for example, 80 mg/dL) at step 440. If it is determinedthat one or more of the predetermined number of consecutive glucosereadings during the pre-sleep time period is higher than thepredetermined target low glucose level at step 440, then the routinereturns to step 410 and awaits to enter the subsequent pre-sleep modeinitiation.

On the other hand, referring back to FIG. 4, if at step 440 it isdetermined that each of the predetermined number of consecutive glucosereadings during the pre-sleep time period is lower or equal to thepredetermined target low glucose level, then at step 450, an alertand/or notification is generated and output to the patient to takecertain predefined and appropriate corrective actions and device statusverifications. Examples of such alerts and/or notifications may includeone or more of a visual, audible, or tactile notification of themeasured consecutive low glucose levels, and a suggestion orrecommendation to ingest a snack and or modify the existing basal rateof the insulin delivery device 120 prior to going to sleep.

In this manner, in one embodiment of the present invention, early onsetof nocturnal hypoglycemic state may be detected and the patient maybenotified prior to going to sleep to take one or more certain appropriatecorrective actions to prevent entering into hypoglycemic state whilesleeping. Suitable alerts or notifications include, for example, but arenot limited to the following:

“Three Pre-sleep Low BGs in a Row—Check Bedtime Basal”,

“Consider Basal Adjustment”,

“Eat a Bedtime Snack”,

In the manner described above, in accordance with one embodiment of thepresent invention, there is provided an approach to prevent or minimizethe potential for nocturnal hypoglycemia for the Type-1 diabeticpatient. Moreover, while the above description of processes and routinesrelated to minimizing nocturnal hypoglycemia is provided in the contextof the insulin delivery device 120, within the scope of the presentinvention, the calculation, determination or any programming and dataprocessing to achieve the functions as set forth in FIG. 3 maybeperformed either alternately or in conjunction with the insulin deliverydevice 120, by the analyte monitoring system 110, or the remote terminal140, as maybe convenient or practical to the patient 130.

FIG. 5 is a flow chart illustrating a notification procedure forimproving blood glucose level control in a patient in accordance withone embodiment of the present invention. Referring to FIG. 5, at stepinsulin delivery device 120 may be configured to retrieve a firstglucose data set based on measured glucose levels of the patient 130 fora first predetermined time period (which may be a 7 day period, forexample). Thereafter at step 520, a first running average glucose levelis determined based on the first the first date set for the firstpredetermined time period. The calculated first running average glucoselevel may be optionally stored in the memory unit 240 of the insulindelivery device 120.

Referring back to FIG. 5, after determining the first running averageglucose level for the first predetermined time period at step 520, asecond glucose data set is retrieved which corresponds to the measuredglucose levels of the patient 130 for a second predetermined time period(for example, a 30 day period). Thereafter, at step 540, a secondaverage glucose level based on the second glucose data set is determinedfor the second predetermined time period. Again, optionally, thecalculated second average glucose level maybe stored in the memory unit240 of the insulin delivery device 120.

Thereafter, referring again to FIG. 5, at step 550, the first averageglucose level is compared with the second average glucose level. If itis determined at step 550 that the first average glucose levels is notless than the second average glucose level, then the routine terminates.On the other hand, if at step 550, it is determined that the firstaverage glucose level calculated based on the first predetermined timeperiod is less than the second average glucose level calculated over thesecond predetermined time period, then at step 560, a predeterminedtarget low glucose level is retrieved (for example, from memory unit240), and at step 570 the retrieved predetermined target low glucoselevel is compared with the first average glucose level calculated atstep 520. In one embodiment, the predetermined target low glucose levelmay be set by the patient or the patient's care provider at a suitablelevel, such as, for example, but not limited or 80 mg/dL.

If at step 570 it is determined that the first average glucose levelcalculated for the first predetermined time period is greater than theretrieved predetermined target low glucose level, then at step 580, anappropriate notification is generated and output to the patient on oneor more of the output unit 260 or the display unit 230 of the insulindelivery device 120. An example of such notification may include“Congratulations!—better BG control than Last Week,” or “Good BG Controlis Worth the Effort!”.

In this manner, one or more of notifications providing encouragements tothe patients maybe provided based on monitored glucose levels so thatthe patients continue to make efforts in controlling and improving theirblood glucose levels. Moreover, while 7 days and 30 days are describedas the predetermined first and second time period, respectively, withinthe scope of the present invention, these time periods maybe altered assuited to each patient and as appropriate so as to accurately andeffectively evaluate monitored glucose levels of the patients overextended periods of time and to provide notifications to the patients.Moreover, within the scope of the present invention, the calculation,determination or any programming and data processing to achieve thefunctions as set forth in FIG. 5 maybe performed either alternately orin conjunction with the insulin delivery device 120, by the analytemonitoring system 110, or the remote terminal 140, as maybe convenientor practical to the patient 130.

FIG. 6 is a flow chart illustrating a notification procedure forimproving blood glucose level control in a patient in accordance withanother embodiment of the present invention. Referring to FIG. 6, atstep 610, a first glucose data set corresponding to the measured glucoselevels of the patient 130 is retrieved for example, from the memory unit240 of the insulin delivery device 120 as received from, for example,the analyte monitoring system 110 (FIG. 1) for a predetermined timeperiod (such as 7 days, or example). Thereafter, a first standarddeviation is determined at step 620 based on the first glucose data set.Thereafter, a second glucose data set for a second predetermined timeperiod (such as 30 days, for example) is retrieved at step 630, and asecond standard deviation based on the second glucose data set isdetermined at step 640.

Referring to FIG. 6, after determining the first and second standarddeviations based on the first glucose data set and the second glucosedata set, respectively, at step 650, the first standard deviation iscompared with the second standard deviation. If at step 650 the firststandard deviation is not less than the second standard deviation, thenthe routine terminates. On the other hand, if at step 650 it isdetermined that the first standard deviation is less than the secondstandard deviation, then at step 660, an output notification isgenerated and output to the patient on one or more of the output unit260 or the display unit 230. Examples of the output notification mayinclude, for example, a notification including “Congratulations!—FewHighs and Lows! Than Last Week” or “Good BG Control is Important!”, orany other suitable notification which corresponds to the glucose levelstandard deviations determined and compared based on the patient'smonitored glucose levels.

Optionally, within the scope of the present invention, the stepoutputting the generated notification may be performed upon the firstreactivation of the insulin delivery device 120 after the routine inFIG. 6 is performed. In this manner, the insulin delivery device 120 maybe configured to provide one or more notifications based on thepatient's monitored glucose levels, and to assist the patient 130 incontinuing to improve monitoring and management of the glucose levels.

In a further embodiment, the patient's analyte levels maybe monitoredover an extended time period such as over a 4-7 day period (forexample), at a specific time of the day (for example, at 7 am everymorning), and the system maybe configured to analyze the obtained ormonitored analyte levels each day at the specified time of day todetermine or generate one or more appropriate patient notifications oralerts to provided to the patient. In this manner, the patient maybeable to improve insulin therapy and diabetes management.

Moreover, within the scope of the present invention, the calculation,determination or any programming and data processing to achieve thefunctions as set forth in FIG. 6 maybe performed either alternately orin conjunction with the insulin delivery device 120, by the analytemonitoring system 110, or the remote terminal 140, as maybe convenientor practical to the patient 130. In addition, in the manner describedabove, any other types of glucose related data may be monitored oranalyzed over a period of time in conjunction with the basal profile ofthe patient 130 to provide a comprehensive insulin therapy managementand diabetes care system.

The various processes described above including the processes performedby the processor 210 in the software application execution environmentin the insulin delivery device 120 as well as any other suitable orsimilar processing units embodied in the analyte monitoring system 120and the remote terminal 140, including the processes and routinesdescribed in conjunction with FIGS. 3-6, may be embodied as computerprograms developed using an object oriented language that allows themodeling of complex systems with modular objects to create abstractionsthat are representative of real world, physical objects and theirinterrelationships. The software required to carry out the inventiveprocess, which may be stored in the memory unit 240 (or similar storagedevices in the analyte monitoring system 120 and the remote terminal140) of the processor 210, may be developed by a person of ordinaryskill in the art and may include one or more computer program products.

Accordingly, a method of diabetes management in one embodiment of thepresent invention includes comparing each of a predetermined number ofconsecutive analyte related levels for a predefined time period to apredetermined target level, and generating an alert when each of thepredetermined number of consecutive analyte related levels deviates fromthe predetermined target level.

The method may further include the step of measuring an analyte level ofa patient to determine the one or more of the predetermined number ofconsecutive analyte related levels, where the measuring step may in oneembodiment include the step of using one or more of a discrete bloodglucose meter or a continuous analyte monitoring system.

The method may further include the step of outputting the alert on aninfusion device.

Moreover, in one embodiment, the predefined time period may include oneof a time period between 30 minutes and four hours.

The predetermined number of consecutive analyte related levels inanother aspect may include one of two, three, four or five analyterelated levels.

Additionally, the predetermined target level may include a target highanalyte level.

The analyte levels may include glucose levels, and the predeterminedtarget level may include a target high glucose level.

The alert may in one embodiment include one or more of an audible alert,a visual alert, or a tactile alert, where the visual alert may includeone or more of an alphanumeric output display, a graphical outputdisplay, an icon display, a video output display, a color display and aillumination display.

The color display may include a change in color of an output image,animation, or background of the display unit 230, for example, and theillumination display may include, for example, but not limited to apersistent or sequential flashing of the backlight feature on thedisplay unit 230.

The method may further include the step of outputting the generatedalert.

The predefined time period in one embodiment may include a pre-sleeptime period, which, in one embodiment may be configured to begin atapproximately a predetermined number of hours post the last meal of theday, and to terminate at the beginning of entering sleep cycle.

Alternatively, the pre-sleep time period maybe configured to begin atapproximately 9 pm and to terminate at approximately at 12 am in a 24hour daily time period.

In a further aspect, the predetermined target level may include a targetlow analyte level, where the alert may be generated when each of thepredetermined number of analyte related levels falls below the targetlow analyte level.

A system for providing diabetes management in accordance with anotherembodiment of the present invention includes an interface unitconfigured to receive one or more analyte related data, a processor unitoperatively coupled to the interface unit, the processor unit configuredto perform data processing based on the one or more received analyterelated data, the processing unit further configured to generate one ormore of an alert or a notification for output via the interface unit,where the processor unit is configured to compare the one or moreanalyte related data to one or more of a predetermined target analytelevels, and in accordance therewith, generate the one or more of thealert or the notification for one or more of an audible output, visualoutput or a tactile output.

The interface unit may include an input unit and an output unit, theinput unit configured to receive the one or more analyte related data,and the output unit configured to output the one or more of the alert ofthe notification.

The processor unit may be configured to receive substantially in realtime, a plurality of analyte levels of a patient.

The interface unit and the processor unit may be operatively coupled toa housing of an infusion device.

The infusion device may include an external insulin pump.

A system for providing diabetes management in accordance with yetanother embodiment includes an analyte monitoring system configured tomonitor an analyte level of a patient substantially in real time, amedication delivery unit operatively for wirelessly receiving dataassociated with the monitored analyte level of the patient substantiallyin real time from the analyte monitoring system, and a data processingunit operatively coupled to the one or more of the analyte monitoringsystem or the medication delivery unit, the data processing unitconfigured to perform data processing based on the monitored analytelevel of the patient, and to generate and output one or more of an alertor notification corresponding to the monitored analyte levels.

The analyte monitoring system may be configured to wirelesslycommunicate with the medication delivery unit over a radio frequency(RF) communication link, a Bluetooth communication link, an Infraredcommunication link, or a local area network (LAN).

Various other modifications and alterations in the structure and methodof operation of this invention will be apparent to those skilled in theart without departing from the scope and spirit of the invention.Although the invention has been described in connection with specificpreferred embodiments, it should be understood that the invention asclaimed should not be unduly limited to such specific embodiments. It isintended that the following claims define the scope of the presentinvention and that structures and methods within the scope of theseclaims and their equivalents be covered thereby.

1. A method of managing hypoglycemia, comprising: programming apre-sleep mode with an interface device, wherein the pre-sleep modeincludes a pre-sleep time period prior to when a patient enters a sleepcycle; detecting the pre-sleep mode with the interface device;comparing, using a processor, one or more of a predetermined number ofconsecutive analyte related levels for the pre-sleep time period to apredetermined target level; and generating, using the processor, analert when one or more of the predetermined number of consecutiveanalyte related levels deviates from the predetermined target level. 2.The method of claim 1 further including measuring an analyte level of apatient to determine the one or more of the predetermined number ofconsecutive analyte related levels.
 3. The method of claim 2 wherein themeasuring the analyte level includes using one or more of a discreteblood glucose meter or a continuous analyte monitoring system.
 4. Themethod of claim 1 further including outputting the alert on themedication delivery unit.
 5. The method of claim 1 wherein thepredetermined target level includes a target upper or lower analytelevel.
 6. The method of claim 5 wherein the alert is generated when oneor more of the predetermined number of analyte related levels reachesthe target upper or lower analyte level.
 7. The method of claim 1wherein the alert includes one or more of an audible alert, a visualalert, or a tactile alert.
 8. The method of claim 7 wherein the visualalert includes one or more of an alphanumeric output display, agraphical output display, an icon display, a video output display, acolor display or an illumination display.
 9. The method of claim 1further including outputting the generated alert.
 10. The method ofclaim 1 wherein the pre-sleep time period begins at approximately apredetermined number of hours after the last meal of the day, andterminates at the beginning of entering the sleep cycle.
 11. The methodof claim 1 wherein generating the alert includes generating a treatmentrecommendation.
 12. A system for managing hypoglycemia, comprising: aprocessor unit configured to perform data processing based on one ormore analyte related data, the processor unit further configured togenerate one or more of an alert or a notification for output; whereinthe processor unit is configured to program a pre-sleep mode including apre-sleep time period prior to when a patient enters a sleep cycle, todetect the pre-sleep mode, to compare the one or more analyte relateddata for the pre-sleep time period to one or more predetermined targetanalyte levels, and to generate the one or more of the alert or thenotification for one or more of an audible output, visual output or atactile output.
 13. The system of claim 12 further including an inputunit and an output unit operatively coupled to the processor unit, theinput unit configured to receive the one or more analyte related data,and the output unit configured to output the one or more of the alert orthe notification.
 14. The system of claim 12 wherein the processor unitis configured to receive substantially in real time, a plurality ofanalyte levels of a patient.
 15. The system of claim 12 wherein theprocessor unit is operatively coupled to a housing of an infusiondevice.
 16. The system of claim 15 wherein the infusion device includesan insulin pump.
 17. A system for managing hypoglycemia, comprising: ananalyte monitoring system configured to monitor an analyte level of apatient substantially in real time; a medication delivery unitoperatively coupled to the analyte monitoring system for wirelesslyreceiving data associated with the monitored analyte level of thepatient substantially in real time from the analyte monitoring system;and a data processing unit operatively coupled to one or more of theanalyte monitoring system or the medication delivery unit, the dataprocessing unit configured to program a pre-sleep mode, wherein thepre-sleep mode includes a pre-sleep time period prior to when a patiententers a sleep cycle, to compare one or more of a predetermined numberof consecutive monitored analyte levels during the pre-sleep time periodto a predetermined target level, and to output one or more of an alertor notification corresponding to the monitored analyte levels.
 18. Thesystem of claim 17 wherein the analyte monitoring system is configuredto wirelessly communicate with the medication delivery unit over a radiofrequency (RF) communication link, a Bluetooth communication link, anInfrared communication link, or a local area network (LAN).
 19. Thesystem of claim 17 wherein the data processing unit is configured togenerate and output an alert when one or more of the predeterminednumber of consecutive monitored analyte related levels reaches thepredetermined target level.